MAUDE manufacturer profile
HOLOGIC, INC. · GDF
MAUDE profile for Guide, Needle, Surgical
Key facts
| Manufacturer | HOLOGIC, INC. |
|---|---|
| Manufacturer group | HOLOGIC, INC. |
| Product code | GDF |
| Product code name | Guide, Needle, Surgical |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Break, Detachment Of Device Component, No Information, No Consequences Or Impact To Patient, Component Falling, Loose or Intermittent Connection, Out-Of-Box Failure Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1